Devices, systems, and methods for percutaneous trans-septal left atrial appendage occlusion

ABSTRACT

A device, system and method for occlusion of the left atrial appendage. A device is described with respect to non-surgically occluding the left atrial appendage with minimal invasiveness. Additionally, a system and method are described for using the device to perform the left atrial appendage occlusion procedure.

PRIORITY

The present application is related to, and claims the priority benefitof, International Patent Application Serial No. PCT/US2008/000838, filedJan. 23, 2008, which is related to, and claims the priority benefit of,U.S. Provisional Patent Application Ser. No. 60/881,831, filed Jan. 23,2007. The contents of each of these applications are hereby incorporatedby reference in their entirety into this disclosure.

BACKGROUND

Currently, 2.2 million patients in the United States suffer atrialfibrillation (“AF”). About half of these patients are considered to beat a high risk for stroke. The Stroke Prevention in Atrial Fibrillationtrials (SPAF, SPAF II, SPAF III) have shown that chronic warfarintherapy reduces the risk of stroke by about 70%. Nevertheless, problemsrelated with the long term use of anti-coagulation treatments are wellknown. It has been shown that up to two-thirds of eligible AF patientsdo not receive warfarin treatment. This can be at least partlyattributed to the fact that warfarin is difficult to dose as it is knownto interact with many commonly-used medications and other chemicals thatmay be present in appreciable quantities in food. Accordingly, saferoptions are desirable.

AF is frequently diagnosed in elderly patients and is responsible formore than 15% of all strokes. This percentage grows to almost 25% inwomen and men older than 80 years of age. Dilation of the left atriumand a reduction of blood flow velocity, especially in the left atrialappendage, is commonly seen with AF. Atrial contraction is responsiblefor blood ejection out of the left atrium and appendage. The dysfunctionof the left atrial contraction is followed by blood stagnation,especially at the level of the atrial appendage. It has beendemonstrated by means of echocardiography and autopsy studies that morethan 90% of all thrombi in patients with non-rheumatic AF beginning inthe left atrium, appear in the left atrial appendage. Thrombus formationelevates the threat of stroke by three-fold.

The left atrial appendage (“LAA”) is an embryonic remnant of the leftatrium that grows during the third week of pregnancy. The left atrialcavity develops soon after and is produced from an outgrowth of thepulmonary veins. The diameter of the LAA ostium into the left atrialcavity is about 1 to 4 cm and is positioned between the left upperpulmonary vein and the left ventricle. The left axis deviation orifice,width, and length are typically about 0.7 to 2 cm, 0.9 to 3.4 cm, and1.3 to 4 cm, respectively. The circumflex branch and the left coronaryartery runs close to the base of the LAA ostium.

The LAA is a long structure with tubular or hooked shape of variablemorphology and size. The LAA wall is trabeculated including muscle bars,known as pectinate muscles. The cavities between the pectinate musclesemerge as “branches” (lobes), “twigs”, or “fine structures.” LAA closuremay be an option in patients who cannot receive anticoagulationtreatment as a result of contraindications or conditions in which thehemorrhage risk is greater than the potential medical benefit.

One of the convention options of treating LAA closure is surgery.However, it is unsuitable for the same high-risk patients who are poorcandidates for warfarin therapy. Accordingly, a safe, accurate andminimally invasive procedure is needed to occlude the LAA.

SUMMARY

Embodiments disclosed herein comprise devices and methods of LAAocclusion that do not require surgery and avoid many of the risksassociated with current methods of LAA occlusion. In one embodiment, astandard trans-septal sheath kit is utilized for percutaneoustransluminal access. A balloon catheter at the tip of the shaft isinflated for occlusion of the LAA orifice or ostium. Thereafter, athree-lumen catheter with a pigtail tip designed for dual functionalityis utilized for suction first, which collapses the LAA, then injectionof magnetic glue to seal the collapsed LAA.

In another exemplary embodiment of the present invention, a plurality ofwire needles are employed to puncture the LAA, and thereafter applymagnetic beads thereon. In one embodiment, biologic glue may also beemployed to seal the LAA. In yet another embodiment, an umbrella-likeclip assembly composed of magnetic rods is introduced through a catheterto the outside of the LAA. The configuration of the magnetic rods may beopened to receive the exterior portion of the LAA, and thereafter closedaround the LAA and secured to a magnetic substance inside the LAA. Inone embodiment, the magnetic rods employ magnetic forces to attract andsecure proper placement of the device

In still another exemplary embodiment, a pigtail catheter is used tointroduce a wire comprised of a shape memory alloy around the base ofthe LAA. In one embodiment, a nitinol wire is used. In application, thewire may be tied around the outside of the base of the LAA, therebymaintaining the seal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side view of at least one embodiment of an occlusionassembly;

FIG. 1B shows a cross-sectional view of at least one embodiment of anocclusion assembly taken along line A-A of FIG. 1A;

FIGS. 2A-2E shows a side view of the occlusion assembly of FIGS. 1A and1B as applied to treat a left atrial appendage;

FIG. 3A shows a side view of at least one embodiment of an occlusionassembly;

FIGS. 3B-D shows side views of the needle wires of the occlusionassembly of FIG. 3A applied to treat a left atrial appendage;

FIG. 3E shows a side view of at least one embodiment of an occlusionassembly as applied to treat a left atrial appendage;

FIG. 3F shows a side view of a left atrial appendage that has beenoccluded using the occlusion assembly of FIGS. 3A-E;

FIGS. 4A-4B show two side views of at least one embodiment of anocclusion assembly as applied to treat a left atrial appendage;

FIG. 5 shows side views of the occlusion assembly of FIGS. 4A-4B inoperation;

FIGS. 6A-6C show various embodiments of a pigtail catheter that may beused to treat a left atrial appendage; and

FIGS. 7-9B shows a side view of the pigtail catheter of FIGS. 6A-6C asapplied to treat a left atrial appendage.

DETAILED DESCRIPTION

Reference will now be made to the embodiments illustrated in thedrawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of scope is intendedby the description of these embodiments.

FIG. 1 shows a side view of one embodiment of an occlusion assembly 10for closing a left atrial appendage. Specifically, the assembly 10 isconfigured for placement within the left atrial appendage (“LAA”) and isdelivered non-surgically through the use of catheterization andpercutaneous transluminal access.

The occlusion assembly 10 comprises a shaft 12, a balloon 14, a catheter16, and a guidewire 18. The shaft 12 comprises an elongated cathetershaft having a proximal end 20, a distal end 22, and an interior 24.Both the proximal end 20 and the distal end 22 of the shaft 12 are openand in communication with the interior 24. The interior 24 of the shaft12 extends throughout the length of the shaft 12 and provides a channelthrough which the distal end 22 of the shaft 12 may be accessed whenpositioned within a body.

The balloon 14 is coupled with the distal end 22 of the shaft 12 and cancomprise any balloon catheter tip known in the art. The balloon 14 maycomprise a tube or other inflation means (not shown) coupled therewithto facilitate the inflation and deflation of the balloon 14 whenpositioned within the body. The balloon 14 can be configured in a rangeof sizes to accommodate the anatomy of the left atrial appendage. In oneembodiment, the balloon 14 comprises a flattened-disk configuration,however it will be understood that the balloon 14 can comprise variousshapes and forms that will assist in the temporary closing and sealingof the LAA cavity, including, without limitation, a hemisphere shape anda wine-bottle cork shape.

The occlusion assembly 10 further comprises a guidewire 18. Theguidewire 18 is configured to be inserted through the interior 24 of theshaft 12 and may be any standard guidewire known in the art. In oneembodiment, the guidewire 18 functions to facilitate navigation of theshaft 12 and catheter 16 into the LAA. Use of the guidewire 18 enablesmore effective navigation of the occlusion assembly 10 and preventsdamage to the atrial or appendage walls.

In one approach, the procedure can be performed under local anesthesiaand conscious sedation. The shaft 12 and the balloon 14 coupledtherewith are inserted through the femoral vein and advanced to theright atrium of the heart. Thereafter, a trans-septal puncture is madeat the level of the fossa ovalis area to access the left atrium. Afterthe shaft 12 and the balloon 14 are positioned within the left atrium,the guidewire 18 is inserted into the LAA, visualized by fluoroscopy ortransesophageal echocardiography, and the shaft 12 is threaded over theguidewire 18 such that the balloon 14 is positioned adjacent to theostium of the LAA. When the balloon 14 is properly positioned, as shownin FIG. 1A, the balloon 14 is inflated to occlude the LAA orifice.

After the shaft 12 and the balloon 14 are properly positioned withrespect to the LAA, the catheter 16 may be introduced. The catheter 16of the occlusion assembly 10 comprises an elongated, flexible tubehaving an exterior wall, a proximal end 30, a distal end 32, a hollowinterior 34, and at least one opening 36 disposed through the exteriorwall. The proximal end 30 of the catheter 16 is in communication withthe interior 34, and the interior 34 extends throughout the length ofthe catheter 16. Accordingly, the interior 34 of the catheter 16provides a channel through which the distal end 32 may be accessed.

The catheter 16 is configured to be slidably positioned within theinterior 24 of the shaft 12. For example, the distal end 32 of thecatheter 16 can be inserted into the proximal end 20 of the shaft 12,advanced through the interior 24 of the shaft 12, and extended into theLAA cavity. In one embodiment, the catheter 16 comprises a length thatis greater than the length of the shaft 12 such that the distal end 32of the catheter 16 can conveniently be extended through the distal end22 of the shaft and into the LAA cavity. Further, in at least oneembodiment, the catheter 16 comprises a three-lumen pigtail catheter,such that the distal end 32 is tightly curled. This tightly curledconfiguration functions to prevent trauma in the event the proximal end32 comes into contact with a vessel or organ wall as the catheter 16 isadvanced through the body of a patient.

The distal end 32 of the catheter 16 comprises at least one opening 36disposed therein. Each of openings 36 located on the distal end 32 is incommunication with the interior 34 of the catheter 16 and comprises aconfiguration such that a force or substance can be transmittedtherethrough. For example, in one embodiment, the at least one opening36 comprises a suction port configured to aspirate an area adjacent tothe catheter 16 when the at least one opening 36 is coupled with avacuum source. In an alternative embodiment, the at least one opening 36comprises a single opening at the distal end 32 of the catheter 16,configured such that the guidewire 18 or other device can be positionedtherethrough. In yet another embodiment, the at least one opening 36 isconfigured to deliver a substance to the surrounding tissue, such as anadhesive or medicament. The number of openings 36 located on the distalend 32 of the catheter 16 may depend on the desired functionality of theocclusion assembly 10, and it will be understood that any number ofopenings 36 may be employed.

As previously described, the interior 34 of the catheter 16 extends fromthe proximal end 30 of the catheter 16 to the distal end 32 of thecatheter 16. Further, the interior 34 is in communication with the atleast one opening 36. Accordingly, the interior 34 of the catheter 16can function as a conduit through which a force, device, and/orsubstance may be delivered to the at least one opening 36. For example,when a vacuum source, such as a syringe or other vacuum source, iscoupled with the proximal end 30 of the catheter 16, the suctional forceproduced thereby can be communicated throughout the interior 34 of thecatheter 16 and through the at least one opening 36 in communicationtherewith. In one embodiment, a syringe or other vacuum source (notshown) may be coupled with the proximal end 30 of the catheter 16 inorder to provide appropriate suction throughout the interior 34 of thecatheter 16. It will be understood that any type of vacuum source may beused to supply suction throughout the interior 34, such as a controlledvacuum system providing specific suction pressures. In anotherembodiment, an adhesive delivery device (not shown) is coupled with theproximal end 30 of the catheter 16. The adhesive delivery device maycomprise any means for advancing an adhesive through the interior 34 ofthe catheter and through the at least one opening 36. For example, inone embodiment, the adhesive delivery device may be a clinician's handwhen he or she applies force to a container of adhesive such that theadhesive is advanced through the interior 34 of the catheter 16. In analternative embodiment, the adhesive delivery device may comprise aspecifically designed mechanism for advancing the adhesive.

Referring now to FIG. 1B, in one embodiment, the interior 34 of thecatheter 16 comprises multiple lumens. In the embodiment shown in FIG.1B, the occlusion assembly 10 comprises a triple-lumen pigtail catheter,wherein the interior 34 comprises a first lumen 42, a second lumen 44,and a third lumen 46. In this embodiment, the first lumen 42 is disposedaround the circumference of the catheter 16 and the second and thirdlumens 44, 46 are disposed centrally within the interior 34. The secondand third lumens 44, 46 are wholly surrounded by the first lumen 42.While this specific configuration is shown with respect to FIG. 1B, itwill be appreciated that the interior 34 may comprise any number oflumens and the lumens can be arranged in any configuration.

The multiple lumens enable the catheter 16 to perform multiple functionswithout withdrawing the catheter 16 from the body or employing more thanone device. For example, a plurality of openings 36 configured toaspirate a tissue may be in communication with the first lumen 42, asingle opening 36 configured to receive the guidewire 18 therethroughmay be in communication with the second lumen 44, and a plurality ofopenings 36 configured to deliver a substance to a tissue may be incommunication with the third lumen 46. In this manner, the catheter 16is capable of various functionalities including, without limitation,delivering suction to the cavity of the LAA, advancing the guidewire 18to ensure accurate navigation throughout the body, and applying anadhesive to the LAA. It will be recognized that the catheter 16 mayfurther comprise any combination of the aforementioned embodiments on asingle device. In addition, the number of openings 36 located on thedistal end 32 of the catheter 16 depend on the desired functionality ofthe occlusion assembly 10, and it will be understood that any number ofopenings 36 may be employed.

The operation of the occlusion assembly 10 will now be described withrespect to the at least one embodiment of the catheter 16 shown in FIG.2A. While this embodiment is described herein, it is understood that anyof the embodiments of the catheters 16 described herein may be used toocclude a LAA.

In operation, the guidewire 18 is threaded through the previouslydeployed shaft 12 and inserted into the cavity of the LAA, visualized byfluoroscopy or transesophageal echocardiography. After the guidewire 18has accessed the cavity of the LAA, the distal end 32 of the catheter 16is advanced through the distal end 22 of the shaft 12 and into thecavity of the LAA as shown in FIG. 2A. While maintaining the inflationof the balloon 14 occluding the LAA ostium, suction is initiated throughthe catheter 16. Specifically, a vacuum source is coupled with the firstlumen 41 such that a vacuum is created therein. In this manner, theplurality of openings 36 function to aspirate the cavity of the LAA.This suctional force is maintained until a small amount of blood isremoved from the LAA cavity and the LAA wall collapses as shown in FIG.2B. After the LAA wall is completely collapsed, the suction is ceased.As the balloon 14 is occluding the LAA ostium and the LAA cavity issealed, the collapse is maintained even in the absence of aspiration.

At this point, the catheter 16 is used to inject an adhesive 47 into thecollapsed LAA cavity. In one embodiment the adhesive 47 comprises abiologic glue, however, the adhesive 47 can comprise any adhesive knownin the medical arts. Accordingly, the occlusion assembly 10 may furthercomprise a delivery apparatus (not shown) for providing the adhesive 47to the catheter 16. In one embodiment, the delivery apparatus is coupledwith the third lumen 46 such that the adhesive 47 is advancedtherethrough and applied to the cavity of the LAA through the at leastone of opening 36 in communication therewith.

As shown in FIG. 2C, the application of the adhesive 47 within thecollapsed LAA functions to seal the LAA. Further, as the catheter 16delivers the adhesive 47 into the LAA cavity, the catheter 16 is slowlywithdrawn through the interior 24 of the shaft 12 (FIG. 2D). After theadhesive 47 has completed sealing, the balloon 14 is deflated.Thereafter, the left atrium of the heart can be injected with dye inorder to show angiographically the LAA occlusion. Once the success ofthe procedure has been confirmed, the shaft 12 and the balloon 14 arewithdrawn from the body, across the interatrial septum and back throughthe femoral vein, thereby leaving the cavity of LAA sealed as shown inFIG. 2E.

Now referring to FIG. 3, an additional embodiment of an occlusionassembly 100 is shown. The occlusion assembly 100 comprises the shaft 12and the balloon 14, and a catheter needle 118. The shaft 12 and theballoon 14 are configured identically to the shaft 12 and the balloon 14of the occlusion assembly 10. Accordingly, configuration of the shaft 12and the balloon 14 will not be described in detail with respect to theocclusion assembly 100, and like reference numerals between FIGS. 1A-2Eand FIGS. 3A-3D will refer to like components.

The catheter needle 118 of the occlusion assembly 100 comprises acatheter 116 comprising a proximal end 130, a distal end 132, a hollowinterior 134, and one or more needle wires 121. The catheter 116 may becomposed of any material known in the medical arts suitable forapplication within the heart. The hollow interior 134 of the catheter116 extends the length of the catheter 116, and in one embodiment, theinterior 134 of the catheter 116 comprises at least two independentlumens.

The needle wires 121 are coupled with the distal end 132 of the catheter116 and extend therefrom. The needle wires 121 are hollow so that amagnetic glue-like substance or other suitable substance (not shown) canpass therethrough. In one embodiment, each of the needle wires 121comprise a lumen extending the length of the needle wire 121 and adistal needle aperture 123 in communication with the lumen. The needlewires 121 may be composed of any suitable material commonly used in themedical arts that serves the functions noted herein including, withoutlimitation, a metallic compound. In one embodiment, the needle wires 121are comprised of a very fine, hollow wire.

The catheter needle 118 can be slidably positioned within the interior24 of the shaft 12. When the needle wires 121 of the catheter needle 118are encased within the interior 24 of the shaft 12, the needle wires 121are necessarily in a closed, joined form. In this manner, a cliniciancan effectively manipulate the catheter needle 118 containing the needlewires 121 in and around a patient's body without the needle wires 121protruding and contacting surrounding tissue. However, once the catheterneedle 118 is properly positioned (e.g., within the atrial appendage), aclinician may advance the catheter needle 118 through the distal end 22of the shaft 12, thereby exposing the needle wires 121 and allowing themto expand as shown in FIG. 3B.

The lumen of each of the needle wires 121 is in communication with thehollow interior 134 of the catheter 116. In the embodiment where thecatheter 116 comprises at least two independent lumens, the lumens ofeach of the needle wires 121 may be in communication with one of thelumens of the catheter 116, some of the lumens of the catheter 116, orall of the lumens of the catheter 116. In one embodiment, the lumen ofeach needle wire 121 is in communication with each of the lumens of thecatheter 116. In this manner, a first lumen of the catheter 116 mayprovide a suctional force through the lumen of the needle wire 121, anda second lumen of the catheter 116 may provide delivery of an adhesiveor medicament through the lumen of the needle wire 121. Alternatively,and in the same manner, a first lumen of the catheter 116 may provide afirst adhesive to the needle wire 121 and a second lumen of the catheter116 may provide a second adhesive to the needle wire 121.

As previously described, the needle wires 121 comprise a distal aperture123. The distal aperture 123 is in communication with the lumen of theneedle wire 118, and as such, in communication with the interior 134 ofthe catheter 116. In this manner a magnetic glue-like substance can beadvanced through the interior of the catheter 116, into the lumen of theneedle wire 118, and delivered to a targeted tissue through the needleaperture 123. Alternatively, a suctional force can be transmittedthrough the needle aperture 123. In one embodiment, the needle wires 121are connected to an injection apparatus (not shown) for glue deliveryvia the hollow interiors of the needle wires 121, and a vacuum source(not shown) to supply the requisite suction necessary to aspirate theLAA cavity.

The needle wires 121 may further have an expanded memory. For example,the needle wires 121 may be initially closed and then expanded onceexposed to a particular temperature or other stimuli. In other words,the needle wires 121 may comprise an original configuration, which mayinclude, without limitation, a bend and/or a curve in the needle wires121. When the needle wires 121 exhibiting their original configurationare positioned within the shaft 12, the original configuration may bealtered (e.g., the needle wires 121 may be straightened while positionedwithin the interior of the shaft 12). When the needle wires 121 arethereafter protracted from the distal end 22 of the shaft 12, theoriginal configuration of the needle wires 121 may then present itself.

The occlusion assembly 100 may be used in conjunction with an injectionapparatus and a magnetic glue-like substance capable of injection by theinjection apparatus. The injection apparatus may comprise any devicecapable of advancing a magnetic glue-like substance into the needlewires 121. The magnetic glue-like substance may exert a sufficientmagnetic force so that when the magnetic glue-like substance ispositioned on the exterior wall of an atrial appendage, the magneticglue-like substance functions to effectively collapse the structure ofthe atrial appendage. The magnetic glue-like substance can be composedof any commonly used adhesive substance known in the medical arts.

In operation, the occlusion assembly 100, the shaft 12 and balloon 14are delivered and deployed as previously described. Specifically, theballoon 14 is inflated and positioned to collect occluding the ostium ofthe LAA. Thereafter, the catheter needle 118 is delivered through theinterior 24 of the shaft 12 (see FIG. 3A) and suction of the LAA cavityis initiated. In one embodiment, the suction can be provided through theneedle apertures 123 of the needle wires 121. In an alternativeembodiment, a vacuum source can be applied directly to the proximal end20 of the shaft 12. The suctional force of the vacuum is maintainedand/or increased until an amount of blood is removed from the LAA cavityand the LAA wall collapses. Even after the wall collapses, a degree ofsuction is maintained through the catheter 116 or the shaft 12 in orderto ensure the balloon 14 maintains optimal position.

Under fluoroscopic and transesophageal echocardiography control, thecatheter needle 118 is advanced through the distal end 22 of the shaft12 and the walls of the LAA are punctured with the needle wires 121 (seeFIG. 3D). The needle wires 121 are capable of completely puncturing theLAA wall, such that the needle apertures 123 of the needle wires 121 arepositioned within the pericardial sac. Due to the relatively thin natureof the needle wires 121, the puncture of the LAA wall has minimal effecton the pressure within the LAA cavity. However, in one embodiment, thesuctional pressure may be slightly increased during this step tofacilitate a constant pressure within the LAA cavity.

While the needle apertures 123 are positioned within the pericardialsac, an amount of magnetite microbeads 57 are delivered through theneedle apertures 123 of the needle wires 121 onto the epicardialsurface. In one embodiment, this delivery is achieved through the use ofthe injection apparatus previously described. The magnetite microbeads57 may be delivered as an adhesive solution, a powder, or as carbondioxide spray. As shown in FIG. 3D, after the first application iscomplete, the needle wires 121 are used to puncture the LAA and deliverthe microbeads 57 to the epicardial surface in multiple locations. Oncea sufficient amount of magnetite microbeads 57 have been applied to theexternal surface of the atrial appendage, the needle catheter 118 may bewithdrawn through the shaft 12 and removed from the body. Alternatively,prior to being withdrawn, the needle catheter 118 may deposit an amountof magnetite microbeads 57 within the interior of the LAA cavity suchthat the magnetite microbeads 57 are distributed between the LAA walltrabecules (pectinate muscles). The catheter 16 (as shown in FIGS.1A-1E) is thereafter introduced into the LAA cavity and an adhesivebiological glue is injected therein to achieve an adequate seal of theLAA ostium (see FIG. 3E).

The inflation of the balloon 14 is maintained during the requisitesealing time and the catheter 16 is withdrawn from the body through theshaft 12. The magnetic attraction between the magnetic beads 57 on theepicardial surface of the LAA and the magnetite beads 57 disposed withinthe interior of the LAA functions to create a constricted and tightenedLAA, thereby promoting the occlusion of the LAA (see FIG. 3F).

Now referring to FIGS. 4A and 4B, another embodiment of an occlusionassembly 200 is shown. The occlusion assembly 200 comprises the shaft 12and the balloon 14, and a catheter 216. The shaft 12 and the balloon 14are configured identically to the shaft 12 and the balloon 14 of theocclusion assembly 10. Accordingly, configuration of the shaft 12 andthe balloon 14 will not be described in detail with respect to theocclusion assembly 100, and like reference numerals between FIGS. 1A-2Eand FIGS. 4A-4B will refer to like components.

In one embodiment, a catheter 216 is used in conjunction with the shaft12 and the balloon 14 to collapse an atrial appendage. The catheter 216comprises a proximal end 220, a distal end 222, and a clip assembly 250extending from the distal end 222 of the catheter 216. The clip assembly250 comprises a magnetic bar 254 and a plurality of ferromagnetic clips255 positioned in an umbrella-like configuration. The magnetic bar 254is removably coupled with the distal end 222 of the catheter 216 suchthat once the clip assembly 250 is anchored to a tissue, the catheter216 can be removed therefrom and withdrawn from the body. Further, in atleast one embodiment, the magnetic bar 254 initially comprises a sheathdisposed thereon to prevent any magnetic attraction between theferromagnetic clips 255 and the magnetic bar 254 prior to deployment ofthe device.

Each of the ferromagnetic clips 255 comprising the clip assembly 250comprises a first end 230 and a second end 232. In addition, each of theferromagnetic clips 255 exhibits a magnetic polarity. The second ends232 of the ferromagnetic clips 255 are hingedly coupled with themagnetic bar 254, such that a hinged apex 257 is formed. From thishinged apex 257, the clip assembly 250 is capable of moving between acompressed position (closed umbrella) and an expanded position (openumbrella).

The ferromagnetic clips 255 are specifically arranged around themagnetic bar 257 such that ferromagnetic clips 255 a magnetic force isgenerated between the components of the clip assembly 250. However, foras long as the sheath is disposed on the magnetic bar 254, the variouscomponents of the clip assembly 250 may be easily maneuvered.

When the clip assembly 250 is positioned in a compressed position, eachof the ferromagnetic clips 255 lay substantially parallel with thecatheter 116 (see FIG. 4A). In addition, the apex 257 of the assembly150 comprises a needle-like surface that is capable of puncturing atargeted tissue. When the ferromagnetic clips 255 are positioned in theexpanded position, the first ends 230 of the clips 255 extend radiallyfrom the magnetic bar 257 such that the ferromagnetic clips 255 arepositioned in the expanded position (see FIG. 4B).

The umbrella-like configuration of the clip assembly 250 enables theclip assembly 250 to puncture a targeted tissue and subsequently anchorthereto. For example, when the ferromagnetic clips 255 are positioned inthe compressed position, the apex 257 of the clip assembly 250 can beused to puncture the tissue of the LAA. Thereafter, the ferromagneticclips 255 in the compressed position are advanced through the puncturehole and into the pericardial space. Once the first ends 230 of theferromagnetic clips 255 clear the puncture hole in the tissue, thecatheter 216 is withdrawn through a pull back technique. As the firstends 230 of the ferromagnetic clips 255 are not as tightly configured asare the second ends 232 which form a needle-like tip, the first ends 230cannot retract through the puncture hole in the tissue. Accordingly, thefirst ends 230 of the ferromagnetic clips 255 to expand radially awayfrom the catheter 216 and into the expanded position.

The magnetic bar 254 remains positioned within the interior of the LAA.At this point, the sheath disposed on the magnetic bar 254 to preventmagnetic interaction between the magnetic bar 257 and the ferromagneticclips 255 is removed. Once the sheath is removed, the magneticattraction between the components of the clip assembly 250 causes theferromagnetic clips 255 to move into the compressed position, therebyapplying pressure to the exterior of the LAA as shown in FIGS. 5A-5C. Inthis manner, a sandwich effect is created around the exterior of the LAAand the LAA cavity is caused to collapse. Once the desired collapse hasbeen achieved, the catheter 216 may be uncoupled from the magnetic bar257 (through unscrewing or some other means) and withdrawn from thebody.

Now referring to FIGS. 6A-9B, at least one embodiment of an occlusionassembly 300 is shown. The occlusion assembly 300 comprises the shaft12, the balloon 14, a catheter 316, a needle wire 318, and a memory wire320. The shaft 12 and the balloon 14 are configured identically to theshaft 12 and the balloon 14 of the occlusion assembly 10. Accordingly,configuration of the shaft 12 and the balloon 14 will not be describedin detail with respect to the occlusion assembly 300, and like referencenumerals between FIGS. 1A-2E and FIGS. 6A-9B will refer to likecomponents.

The occlusion assembly 300 comprises a catheter 316, a needle wire 318,and a memory wire 320. The catheter 316 comprises a preformed pigtailcatheter having a plurality of lumens. FIGS. 6A-6C illustrate variousconfigurations of the catheter 316, although the catheter 316 maycomprise any other configuration capable of advancing the memory wire320 through the base of the LAA. In one embodiment, the catheter 316comprises three lumens: a first lumen coupled with a vacuum device, asecond lumen for receiving a guide wire, and a third lumen for receivingthe memory wire 320 and the needle wire 318. The memory wire 320 may bemade of a shape memory alloy, such as nitinol. Thus, the wire 320 isrelatively straight when deployed through the catheter 316. However,after introduction into the body and placement around the atrialappendage, by manipulating the wire to wrap around the appendage, thewire forms the shape of a loop. In one embodiment, the memory wire 320is relatively short and is employed with a separate wire guide tofacilitate accurate placement.

The catheter 316 is delivered into the LAA and suction is appliedthereto as previously described herein. The needle wire 318 is advancedthrough the shaft 12, and is used to puncture the base of the LAA, asshown in FIG. 7. After the LAA wall is punctured, the atraumatic guidewire 18 is introduced into the puncture hole and advanced through theLAA wall and into the pericardial space. Once the puncture hole ismaintained by the guide wire 18, the needle wire 318 is withdrawn backinto the LAA and thereafter removed from the body.

The catheter 316 is then advanced, following the guide wire 18, throughthe puncture in the LAA wall. Further, the pigtail configuration of thecatheter 316 is utilized to wrap around the base of the LAA, as shown inFIG. 8. At this point, the guide wire 18 is withdrawn and removed, andthe wire guide is advanced in its place. The wire guide functions topush and deliver the short memory wire 320 to the base of the LAA.Accordingly, the wire guide effects the placement of the memory wire 320through pushing and pulling the memory wire 320 around the base of theLAA as shown in FIG. 9. In this manner, the two ends of the memory wire320 are crossed around the base of the LAA. Concurrent with themanipulation of the memory wire 320, the catheter 316 is slowlywithdrawn from the LAA cavity through the shaft 12. Due to the shapememory alloy properties of the memory wire 320 and its placement aroundthe base of the LAA, the memory wire 320 effectively occludes the LAAwithout the use of adhesives or sutures.

While various embodiments of devices, systems, and methods for occludingthe LAA have been described in considerable detail herein, theembodiments are merely offered by way of non-limiting examples. Manyvariations and modifications of the embodiments described herein will beapparent to one of ordinary skill in the art in light of the disclosure.It will therefore be understood by those skilled in the art that variouschanges and modifications may be made, and equivalents may besubstituted for elements thereof, without departing from the scope ofthe disclosure. Indeed, this disclosure is not intended to be exhaustiveor to limiting. The scope of the disclosure is to be defined by theappended claims, and by their equivalents.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described. Asone of ordinary skill in the art would appreciate, other sequences ofsteps may be possible. Therefore, the particular order of the stepsdisclosed herein should not be construed as limitations on the claims.In addition, the claims directed to a method and/or process should notbe limited to the performance of their steps in the order written, andone skilled in the art can readily appreciate that the sequences may bevaried and still remain within the spirit and scope of the presentdisclosure.

It is therefore intended that this description and the appended claimswill encompass, all modifications and changes apparent to those ofordinary skill in the art based on this disclosure.

The invention claimed is:
 1. A device for occluding an atrial appendage,comprising: a shaft comprising a first hollow interior, an exteriorsurface, a first open end, a second open end, and an inflatable ballooncoupled to the exterior surface; a catheter slidably positioned withinthe interior of the shaft, the catheter comprising a proximal end, adistal end, an exterior surface, a second hollow interior, and at leastone opening communicating from the second interior to the exteriorsurface adjacent to the distal end; a vacuum source operatively coupledwith the interior of the catheter and capable of providing suctionthrough the at least one opening; an adhesive delivery deviceoperatively coupled with the interior of the catheter and capable ofdelivering an adhesive through the at least one opening; and a pluralityof needle wires, the proximal ends of which are coupled with the distalend of the catheter and slidably positioned within the interior of theshaft, the plurality of needle wires moveable between a closedconfiguration and an expanded configuration, and each needle wirecomprising a hollow interior and an aperture at the distal end thereof,the hollow interior communicating between the interior of the catheterand the aperture; wherein the inflatable balloon is configured to sealan ostium of the atrial appendage when the device is positioned withinthe atrial appendage and the balloon is inflated, and operation of thevacuum source creates a vacuum within the sealed atrial appendage,thereby causing the atrial appendage to collapse; wherein the vacuumsource is capable of providing suction through the second open end; andwherein the adhesive delivery device is capable of delivering anadhesive through the apertures of the plurality of needle wires.
 2. Thedevice of claim 1, wherein the interior of the catheter furthercomprises a first lumen and a second lumen, wherein the first lumen iscoupled with the vacuum source and the second lumen is coupled with theadhesive delivery device.
 3. The device of claim 2, wherein the interiorof the catheter further comprises a third lumen.
 4. The device of claim3, further comprising a guidewire slidably positioned within the thirdlumen.
 5. The device of claim 3, wherein the first lumen is disposedaround a circumference of the catheter.
 6. The device of claim 5,wherein the at least one opening comprises a plurality of openings inthe exterior surface of the catheter, the plurality of openings incommunication with the first lumen.
 7. The device of claim 3, whereinthe catheter comprises a pigtail catheter.
 8. The device of claim 2,wherein the first lumen is disposed around a circumference of thecatheter.
 9. The device of claim 2, wherein the at least one opening ofthe catheter comprises a first set of openings and a second set ofopenings, the first set of openings in communication with the firstlumen of the catheter and the second set of openings in communicationwith the second lumen of the catheter.
 10. The device of claim 2,wherein the first lumen is disposed around a circumference of thecatheter.
 11. The device of claim 10, wherein the at least one openingcomprises a plurality of openings in the exterior surface of thecatheter, the plurality of openings in communication with the firstlumen.
 12. The device of claim 1, wherein operation of the adhesivedelivery device causes the adhesive to be delivered into the atrialappendage.
 13. The device of claim 12, wherein operation of the adhesivedelivery device causes adhesive to be delivered within the atrialappendage, thereby causing the atrial appendage to be sealed shut. 14.The device of claim 1, wherein the interior of the shaft extends fromthe proximal end of the shaft to the distal end of the shaft and theinterior of the catheter extends from the proximal end of the catheterto the distal end of the catheter.
 15. The device of claim 1, whereinthe vacuum source comprises a syringe.
 16. The device of claim 1,wherein the adhesive delivery device comprises a container of adhesiveconfigured for manual operation.
 17. The device of claim 1, wherein thecatheter comprises a pigtail catheter.
 18. The device of claim 1,wherein the adhesive comprises a biologic glue.
 19. The device of claim1, wherein the adhesive comprises a ferromagnetic glue.
 20. The deviceof claim 1, wherein the plurality of needle wires comprise the closedconfiguration when the plurality of needle wires are enclosed within theshaft.
 21. The device of claim 1, wherein the plurality of needle wirescomprise the expanded configuration when the plurality of needle wiresare within the atrial appendage.
 22. The device of claim 1 wherein theplurality of needle wires are capable of puncturing the atrialappendage.
 23. The device of claim 1, wherein the vacuum source iscapable of providing suction through the apertures of the needle wires.24. The device of claim 1, wherein the first lumen is disposed around acircumference of the catheter.
 25. A device for occluding an atrialappendage, comprising: a shaft comprising a first hollow interior, anexterior surface, a first open end, a second open end, and an inflatableballoon coupled to the exterior surface; a catheter slidably positionedwithin the interior of the shaft, the catheter comprising a proximalend, a distal end, an exterior surface, a second hollow interior, and atleast one opening communicating from the second interior to the exteriorsurface adjacent to the distal end; a vacuum source operatively coupledwith the interior of the catheter and capable of providing suctionthrough the at least one opening; an adhesive delivery deviceoperatively coupled with the interior of the catheter and capable ofdelivering an adhesive through the at least one opening; and a pluralityof needle wires, the proximal ends of which are coupled with the distalend of the catheter and slidably positioned within the interior of theshaft, the plurality of needle wires moveable between a closedconfiguration and an expanded configuration, and each needle wirecomprising a hollow interior and an aperture at the distal end thereof,the hollow interior communicating between the interior of the catheterand the aperture; wherein the inflatable balloon is configured to sealan ostium of the atrial appendage when the device is positioned withinthe atrial appendage and the balloon is inflated, and operation of thevacuum source creates a vacuum within the sealed atrial appendage,thereby causing the atrial appendage to collapse; wherein the vacuumsource is capable of providing suction through the second open end;wherein the adhesive delivery device is capable of delivering anadhesive through the apertures of the plurality of needle wires; whereinthe first lumen is disposed around a circumference of the catheter; andwherein the interior of the shaft extends from the proximal end of theshaft to the distal end of the shaft and the interior of the catheterextends from the proximal end of the catheter to the distal end of thecatheter.
 26. A method for occluding an atrial appendage comprising thesteps of: providing a device for occluding an atrial appendagecomprising: a shaft comprising a first hollow interior, an exteriorsurface, a first open end, a second open end, and an inflatable ballooncoupled to the exterior surface, a catheter slidably positioned withinthe interior of the shaft, the catheter comprising a proximal end, adistal end, an exterior surface, a second hollow interior, and at leastone opening communicating from the second interior to the exteriorsurface adjacent to the distal end, a vacuum source operatively coupledwith the interior of the catheter and capable of providing suctionthrough the at least one opening, an adhesive delivery deviceoperatively coupled with the interior of the catheter and capable ofdelivering an adhesive through the at least one opening, and a pluralityof needle wires, the proximal ends of which are coupled with the distalend of the catheter and slidably positioned within the interior of theshaft, the plurality of needle wires moveable between a closedconfiguration and an expanded configuration, and each needle wirecomprising a hollow interior and an aperture at the distal end thereof,the hollow interior communicating between the interior of the catheterand the aperture, wherein the inflatable balloon is configured to sealan ostium of the atrial appendage when the device is positioned withinthe atrial appendage and the balloon is inflated, and operation of thevacuum source creates a vacuum within the sealed atrial appendage,thereby causing the atrial appendage to collapse, wherein the vacuumsource is capable of providing suction through the second open end, andwherein the adhesive delivery device is capable of delivering anadhesive through the apertures of the plurality of needle wires;delivering the shaft and catheter to the atrial appendage through apercutaneous intravenous route; inflating the balloon at the ostium ofthe atrial appendage such that the ostium is sealed; collapsing thewalls of the atrial appendage through operation of the vacuum sourcewhile the balloon is inflated to seal the ostium of the atrialappendage; and injecting an adhesive into the collapsed atrialappendage, thereby sealing the collapsed atrial appendage; and removingthe shaft and catheter from the atrial appendage.
 27. The method ofclaim 26, wherein delivering the shaft and catheter to the atrialappendage further comprises the step of performing transseptalprocedure.
 28. The method of claim 26, wherein the step of collapsingthe walls of the atrial appendage through operation of the vacuum sourcefurther comprises: advancing the distal end of the catheter into theatrial appendage; and applying suction to the interior of the atrialappendage through the at least one opening of the catheter.
 29. Themethod of claim 26, wherein the step of injecting an adhesive into thecollapsed atrial appendage further comprises: advancing the distal endof the catheter into the atrial appendage; and operating the adhesivedelivery device such that an amount of adhesive advances through theinterior of the catheter and through the at least one opening.
 30. Themethod of claim 28, wherein the step of injecting an adhesive into thecollapsed atrial appendage further comprises: advancing the distal endof the catheter into the atrial appendage; and operating the adhesivedelivery device such that an amount of adhesive advances through theinterior of the catheter and through the at least one opening; whereinthe collapsed atrial appendage is filled with adhesive.
 31. The methodof claim 26 further comprising the steps of: deflating the balloon; andwithdrawing the shaft and catheter through a percutaneous intravenousroute.
 32. A method for occluding an atrial appendage comprising thesteps of: providing a device comprising: a shaft comprising a firsthollow interior, and exterior surface, a first open end, a second openend, and an inflatable balloon coupled with the exterior surface, acatheter slidably positioned within the interior of the shaft, thecatheter comprising a proximal end, a distal end, an exterior surface, asecond hollow interior, and at least one opening communicating from thesecond interior to the exterior surface adjacent to the distal end, aplurality of needle wires coupled with the distal end of the catheterand slidably positioned within the interior of the shaft, the pluralityof needle wires moveable between a closed configuration and an expandedconfiguration, and each of the plurality of needle wires comprising ahollow interior and an aperture, the hollow interior communicating withthe interior of the catheter and the aperture, a vacuum sourceoperatively coupled with the interior of the shaft and capable ofproviding suction through the second open end, and an adhesive deliverydevice operatively coupled with the interior of the catheter and capableof delivering an adhesive through the apertures of the plurality ofneedle wires, wherein the inflatable balloon is configured to seal anostium of the atrial appendage when the device is positioned within theatrial appendage and the balloon is inflated, the plurality of needlewires are moveable to an expanded configuration when advanced throughthe second open end of the shaft, and operation of the vacuum sourcecreates a vacuum within the sealed atrial appendage, thereby causing theatrial appendage to collapse, wherein the vacuum source is capable ofproviding suction through the second open end; and wherein the adhesivedelivery device is capable of delivering an adhesive through theapertures of the plurality of needle wires; delivering the shaft and thecatheter to the atrial appendage through a percutaneous intravenousroute; inflating the balloon at the ostium of the atrial appendage suchthat the ostium is sealed; collapsing the walls of the atrial appendagethrough operation of the vacuum source; and puncturing the walls of theatrial appendage at a first location by advancing the catheter throughthe second open end of the shaft.
 33. The method of claim 32, furthercomprising the steps of: withdrawing the plurality of needle wires fromthe walls of the atrial appendage; and puncturing the walls of theatrial appendage at a second location by advancing the catheter throughthe second open end of the shaft.
 34. The method of claim 32, furthercomprising the steps of: delivering a first adhesive to the exteriorwalls of the atrial appendage; and delivering a second adhesive to theinterior walls of the atrial appendage.
 35. The method of claim 34,wherein the first adhesive comprises a magnetic adhesive having a firstpolarity, and the second adhesive comprises a magnetic adhesivecomprising a second polarity.
 36. The method of claim 35, wherein thestep of delivering a first adhesive to the exterior walls of the atrialappendage further comprises the step of: advancing the first adhesivethrough the aperture of each of the plurality of needles throughoperation of the adhesive delivery device.
 37. The method of claim 36,wherein the step of delivering a second adhesive to the exterior wallsof the atrial appendage further comprises the steps of: providing adevice comprising: a second catheter slidably positioned within theinterior of the shaft, the catheter comprising a distal end, aninterior, and at least one opening disposed through the distal end,wherein the adhesive delivery device is operatively coupled with theinterior of the second catheter and capable of delivering the secondadhesive through the at least one opening in the second catheter;withdrawing the first catheter from the interior of the shaft; injectingthe second adhesive into the collapsed atrial appendage; and sealing thecollapsed atrial appendage.
 38. A method for occluding an atrialappendage, comprising the steps of: percutaneously and intravascularlyintroducing a portion of a device for occluding an atrial appendagethrough a blood vessel, into a heart, and into the atrial appendage, thedevice comprising: a shaft defining a first hollow interiortherethrough, an exterior surface, a first open end, a second open end,and having an inflatable balloon coupled thereto, the inflatable balloonconfigured to seal an ostium of the atrial appendage upon inflation; acatheter slidably positioned within the first hollow interior of theshaft, the catheter comprising a proximal end, a distal end, an exteriorsurface, and defining a second hollow interior therethrough and at leastone opening at or near a distal end of the catheter in communicationwith the second hollow interior; an adhesive delivery device coupledwith the interior of the catheter and configured to deliver an adhesivethrough the at least one opening; a vacuum source operatively coupledwith the interior of the catheter and capable of providing suctionthrough the at least one opening; and a plurality of needle wires, theproximal ends of which are coupled with the distal end of the catheterand slidably positioned within the interior of the shaft, the pluralityof needle wires moveable between a closed configuration and an expandedconfiguration, and each needle wire comprising a hollow interior and anaperture at the distal end thereof, the hollow interior communicatingbetween the interior of the catheter and the aperture; wherein theinflatable balloon is configured to seal an ostium of the atrialappendage when the device is positioned within the atrial appendage andthe balloon is inflated, and operation of the vacuum source creates avacuum within the sealed atrial appendage, thereby causing the atrialappendage to collapse; wherein the vacuum source is capable of providingsuction through the second open end; and wherein the adhesive deliverydevice is capable of delivering an adhesive through the apertures of theplurality of needle wires; positioning the balloon at the ostium of theatrial appendage; inflating the balloon to seal the ostium; andoperating the vacuum source operatively coupled to the catheter tocollapse the atrial appendage while the balloon is inflated to seal theostium of the atrial appendage.
 39. The method of claim 38, furthercomprising the steps of: injecting an adhesive into the collapsed atrialappendage to seal the collapsed atrial appendage; and removing the shaftand catheter from the sealed atrial appendage.
 40. The method of claim39, wherein the adhesive delivery device further comprises a pluralityof needle wires, and wherein the step of injecting is performed toinject the adhesive through the plurality of needle wires into thecollapsed atrial appendage.